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Behind the headlines: Is a new Alzheimer’s treatment in sight?
You may have seen exciting headlines about a possible new treatment for Alzheimer’s disease. But with so many stories about possible new dementia drugs making the news it can be difficult to know how significant these reports might be.
What has happened?
The Pharmaceutical company Biogen plans to file for US marketing approval for aducanumab, an experimental treatment for early Alzheimer’s disease.
This means Biogen believes that their clinical trials show that the drug is safe and able to improve the symptoms of people with Alzheimer’s. If aducanumab gains regulatory approval, it would be the first new Alzheimer’s drug for nearly 20 years and the very first that works by tackling brain changes that cause the disease, rather than helping with symptoms alone.
Importantly, we haven’t yet seen the full data from these trials and the results haven’t been scrutinised by outside experts.
What is aducanumab?
Aducanumab is an antibody designed to target and remove amyloid, a protein that builds up in the brains of people with Alzheimer’s at an early stage in the disease process. People included in the trials of this drug had early memory problems as well as a PET brain scan confirming a build-up of amyloid in the brain.
Aducanumab is given to patients by a monthly infusion.
How has it been tested?
Aducanumab has been developed and tested over many years. Two final-stage, phase III clinical trials called, ENGAGE and EMERGE, were designed to evaluate the potential benefits and assess the safety of aducanumab in people with a confirmed diagnosis of mild cognitive impairment (MCI) or mild Alzheimer’s disease.
The trials involved over 3000 people who took part in the study at sites across the US and Europe. Alzheimer’s Research UK helped to support recruitment to this research through our involvement with the Join Dementia Research (JDR) service.
Weren’t trials of this drug unsuccessful?
In March, Biogen and Eisai, another pharmaceutical company who collaborated on the drug, announced that they would stop the two phase-III trials of aducanumab early. An initial analysis suggested that the trials were unlikely to improve people’s memory and thinking sufficiently by the end of the trial.
What has changed?
They have now carried out a new analysis involving additional data that became available more recently. They say this shows that aducanumab not only reduces amyloid in the brain but can also slow the decline of memory and thinking skills and people’s ability to carry out activities of daily life.
The new findings were apparently a result of people having taken aducanumab over a longer period of time than when they ran the earlier analysis. The results they have presented so far suggest that higher doses of the drug are important for a clinical effect.
What next?
This is exciting news but with so many people desperate for a new Alzheimer’s treatment we need to hold on and be sure that regulators are satisfied that this drug is safe and effective, and while we hope that they will be, there is no guarantee at this stage.
Biogen now aims to offer aducanumab to eligible patients previously enrolled in the clinical trials. Before anyone else can receive the drug, it will be reviewed by the Food and Drug Administration (FDA), the organisation that regulates drugs in the US. Biogen plans to file an application to the FDA in early 2020 and this process can take up to a year.
They will need to work with the regulator in Europe before it could be available in this country. The National Institute for Health and Care Excellence would then have to weigh the benefits of the drug against its cost before deciding whether it would be provided on the NHS.
This can be a long process, but Alzheimer’s Research UK has been working in preparatory plans for some time with other organisations to ensure that any approved new treatment can get into the hands of patients as quickly as possible.
“People affected by Alzheimer’s have waited a long time for a life-changing new treatment and this exciting announcement offers new hope that one could be in sight.“Taking another look at aducanumab is a positive step for all those who took part in the clinical trials and the worldwide dementia research community. As more data emerges, we hope it will spark global discussions about the next steps for delivering much-needed treatments into people’s hands.
“The FDA will now assess the new data and its strengths and limitations before deciding about whether aducanumab should be made widely available in the US. At Alzheimer’s Research UK, we are already bringing together regulators and drug developers to help speed up the delivery of promising new treatments towards patients. This important work now has renewed urgency.
Hilary Evans, Chief Executive at Alzheimer’s Research UK
How can I get involved in research?
Biogen are no longer recruiting people to trials of aducanumab, but if you are interested in taking part in other dementia research studies or have any questions about this new announcement you can get in touch with our Dementia Research Infoline at infoline@alzheimersresearchuk.org or by calling 0300 111 5 111.
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Robin Brisbourne
Team: Science news
What wonderful news about the new drug Aducanumab, hopefully to become available after all the trials have been completed and is safe for patients suffering from Alzheimer’s to begin taking. This may change people’s lives immeasurable and give hope to so many.
I look forward for some thing as my partner has it and it would be just to have him better than he is now
It was a big shock to find I had such a health problem which explained why I suddenly stopped writing, teaching etc. There still seems to be little that csn be done especially as mostly it is part of growing old. However I am acquainted to a few other women who have similar problems and my husband and some of his friends also complain of being not as smart as they had been.
It would be great if we could stay brainy for a bit longer and have more time to pass knowledge and experience (and remember funny jokes) to the younger generations.
I have witnessed what dementia/altzheimer can do to people. I hope this is a major breakthrough and also , if trials prove to be accurate, then it should be made available as soon as possible
Already given
At long last possible new Hope and not a false dawn !!
Fingers crossed it may the first step to finding a possible cure – and not just temporary brake !!
This news really gives one hope. My husband has Alzheimers and it would be wonderful to slow the inevitable decline .
I would love to know when it might be available
Dear Judy, the recent news about aducanumab is very hopeful. However, it could be a few years before it becomes available as a treatment in the UK.
Initially the drug will be offered to the volunteers who previously took part in the original clinical trials, that ended in March this year. Then, if the FDA approve the drug next year, it would be made available as a treatment in America. We hope that if this happens the drug could then be approved for use in other countries. The National Institute for Clinical Excellence in the UK would then have to decide whether the drug will be available as a treatment on the NHS.
Oh dear , I feel the marbles will have departed before all that happens !
Think you are right
seeing it was about 4 years before anyone but my husband had noticed I had changed and also I was complaining about seeing weird arches.
This is such good news for everyone who has or who may get Alzheimer’s/dementia in the future. I hope more research and tests are going to bring this drug to anyone and will be available as soon as it is proven to be helpful.
This is wonderful news. Is there any chance of my being one of the first to be prescribed this drug. I was diagnosed at the beginning of this year.
Dear Ann, the recent news about aducanumab is very hopeful. However, initially the drug will be offered to the volunteers who previously took part in the original clinical trials.
Then, if the FDA approve the drug next year, it would be made available as a treatment for people in America first. We hope that if this happens the drug could then be approved for use in other countries. The National Institute for Clinical Excellence in the UK would then have to decide whether the drug will be available as a treatment on the NHS. This process could take a few years.
I am just verifying my name and e mail add.
I so hope that it’s available soon as I’ve just been diagnosed with dementia/altzeimers. Waiting to see specialists confirmation of the type. Fingers crossed it works.
I have been recently diagnosed with Altzeimers as was my Mother some years ago. I would be happy to become involved in research
Hi Rosemrey, the best way to get involved in research is via a service called Join Dementia Research, which is run by the NHS.
When you register you provide information about yourself, which is then used to match you to approved research studies in your local area that you are eligible to take part in. You can find out more information and register to Join Dementia Research here https://www.joindementiaresearch.nihr.ac.uk/beginsignup
We can also help you register over the telephone if you’d prefer, the process takes 10-15 minutes, 0300 111 5111 (Monday to Friday 9-5pm).
That still does not sound very promising for those of us who already have been suffering a few years. We are all doomed eventually anyway…
Please keep me informed.
WILL A PET SCAN PROVIDE DIAGNOSTIC EVIDENCE OF ALZHEIMERS PRIOR TO MANIFESTATION OF CLINICAL SIGNS OF INTELLECTUAL IMPAIRMENT?
Dear David, the people who took part in the clinical trials for aducanumab had PET scans to ensure they had a build-up of amyloid in their brains and would therefore potentially benefit from this anti-amyloid treatment. These volunteers already had mild symptoms, and the PET scans helped researchers to determine that these were likely due to Alzheimer’s rather than another form of dementia.
A PET scan or a lumbar puncture can indicate amyloid build-up before symptoms of cognitive and intellectual impairment appear, but Alzheimer’s is a complex disease and not everyone with higher levels of amyloid will go on to develop dementia.
While lumbar punctures may occasionally be used to help support a diagnosis of Alzheimer’s, amyloid PET scans are not currently part of diagnostic guidelines but they are a valuable tool for research.
Identifying brain changes such as amyloid build-up early, before such symptoms show, is important. Because new treatments such as aducanumab may work best if they are given at the earliest possible stage.
There is hope that much simpler blood test that identifies amyloid build up may become available in the near future, you can read about this here https://www.dementiablog.org/when-will-there-be-a-blood-test-for-alzheimers/
My husband has Alzheimer’s disease. He is still at the moderate stage and it would be fantastic if this drug proves to be effective and safe to take that it becomes available soon. It affects so many people and cost should not be a consideration.
My husband took part in the biogen clinical trials, we are hoping he will be offered the drug again. The research process is rigorous with monthly intravenous infusions, regular CT scans and psychometric evaluation. We engaged in this research via the join dementia research website.
Hi Anne, it is great to hear of your husband’s involvement in the Biogen clinical trials.
We are always interested to hear from people who have been involved in dementia research so please do email stories@alzheimersresearchuk.org if you would be happy to share yours and your husband’s experience.
Hi,
This sounds a fantastic opportunity, for all of those suffering and in the future.
Myself and members of my family, are very concerned, as we are not sure, if Alzheimer’s is hereditary. My great grandmother and great aunt had either Alzheimers or Dementia, we are not sure which. My mother had both and my aunt has Alzheimers. This is particularly worrying to myself, as my memory has always been poor and is getting a lot worse ,as time goes by.
Also this is very distressing, to watch someone you love, suffer so much.
Thank goodness for your continued research and good luck as it progresses
Dear Cheryl,
Unfortunately, because dementia is so common, many people may have multiple close relatives who have the condition. The majority of Alzheimer’s disease is not directly inherited and is caused by a combination of factors including our age, genetics, environmental and health factors. If you would like to find out more about genetics and dementia you can do so on our website here https://alzheimersresearchuk.org/about-dementia/helpful-information/genes-and-dementia/
There are many reasons for memory loss, for example some medications, depression, anxiety and vitamin deficiency can cause forgetfulness. Your GP is the first person you should contact if you have concerns regarding your memory. Depending upon the course of discussion with your GP, they may ask you to take a memory test or refer you for other tests to determine the cause of your forgetfulness.
You may find the following leaflet helpful, as it provides information about what to do if you are concerned about your memory: https://alzheimersresearchuk.org/wp-content/plugins/mof_bl_0.2.9/downloads/MEM-0619-0621_JULY%202019_WEB.pdf
If you would like to talk to someone about your experiences or get some support on caring for someone with dementia, Alzheimer’s Society are a charity who focus on the support and care of people with dementia. They can be contacted on 0300 222 1122 or email enquiries@alzheimers.org.uk.
I find this encouraging but also frustrating as it will only depend on early diagnosis. I feel for anyone with this terrible illness, and commend you for your strength in the face of it. The problem as I see it is that medical experts don’t recognise the signs early enough and budgets don’t always allow for PET scans etc. We started noticing changes in my sister behaviour at 47years. Eventually after 3 years of constantly visiting the Doctor she got to see a consultant who told us that she was depressed and by telling her that she would recover. I respectfully disagreed with this and we paid to see a further consultant who diagnosed her on her first visit (only approximately a month after the previous). She is now 52 and some way down the journey of the illness. I feel angry that it took so long and the signs weren’t picked up earlier. Although unfortunately this may be too late for many it at least shows that there may be some light at the end of the tunnel. It would be good to hold it at bay as long as possible. For most sufferers however unfortunately it seems a long way off and out of reach.
Confirmation